FDA recall Z-0958-2023

Abbott Laboratories · Class III · device

Product

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Reason for recall

Reaction vessels may contain a potential contaminant that could affect their optical performance.

Distribution

US Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WV

Key facts

Status
Ongoing
Initiation date
2022-11-24
Report date
2023-01-25
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irving, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0958-2023